Principal Research Scientist – Clinical Development

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $79.8k - $139.6k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Responsible for coordinating and carrying out the full spectrum of activities related to the development and validation of bioanalytical methods according to client requests and within the required timeframes • Develops a solid understanding of clinical trial design and applies this knowledge to support the creation of study concept documents and clinical protocols • Participates in protocol review meetings, contributing to discussions on scientific rationale and operational study design considerations • Assists in the preparation of study protocols, protocol amendments, investigator meeting materials, study manuals, and other clinical trial documentation under appropriate guidance • Contributes to the development of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans with supervision • Supports responses to investigator inquiries related to scientific, clinical, and procedural aspects of studies • Assists in the preparation and review of data outputs, summary reports, study findings, manuscripts, and scientific presentations • Provides support in the development and review of regulatory submission documents • Identifies and helps address moderately complex study-related challenges, implementing solutions with guidance from experienced team members • May coordinate project teams and provide direction on assigned activities when required • May perform clinical monitoring responsibilities for individual studies or specific components of larger clinical programs • Demonstrates the ability to quickly learn new therapeutic areas and synthesize relevant scientific literature to support study development activities • Ensures compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs).

🎯 Requirements

• PharmD or PhD with 3+ years in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment • MS with 6+ years’ relevant scientific and/or drug development experience • BS or RN with 8+ years’ relevant scientific and/or drug development experience • Relevant experience in Multiple Myeloma and/or CAR-T Therapy is preferred • Experienced with Microsoft Office and other job-related programs • Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel and analytical software (E.g. Analyst) • Demonstrates skills in scientific problem solving • English level: Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time